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WishFIX PK-EFC0212SS-08-US

by Wishbone Medical Inc.

WishFIX PK-EFC0212SS-08-US is a Class II device made by Wishbone Medical Inc., cleared under FDA 510(k) K182704 on 25 Jun 2019 and listed in FDA GUDID since 15 Dec 2021 (UDI-DI B562PKEFC0212SS08US0), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

510(k) K182704

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB562PKEFC0212SS08US0 UDI-DI Date15 Dec 2021ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK182704 Date25 Jun 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K182704 decided 25 Jun 2019 Active
  • FDA GUDID UDI-DI B562PKEFC0212SS08US0 listed 15 Dec 2021 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1808-2024 FDA Class II initiated 5 Apr 2024

    The products in this lot are incorrectly packed with a Stainless-Steel implant instead of a Titanium implant as the packaging and part number indicated.

Timeline

3 dated events

  1. Cleared FDA 510(k) K182704
  2. Listed FDA GUDID B562PKEFC0212SS08US0
  3. Recall initiated FDA recalls Z-1808-2024

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
WishFIX
Generic name
Orthopaedic fixation plate, non-bioabsorbable
Model / Ref / Catalog
PK-EFC0212SS-08-US, PK-EFC0212SS
Primary DI / UDI-DI
B562PKEFC0212SS08US0
510(k) Number
FDA product code
OBT
GMDN term
Orthopaedic fixation plate, non-bioabsorbable
Device class
Class II
Regulation number
888.3030
GUDID distribution status
Not in Commercial Distribution

Related devices

Category: Orthopaedic fixation plate, non-bioabsorbable

Cleared under the same submission (K182704)

and 8 more cleared under K182704

Similar devices in this category

Other devices filed under Orthopaedic fixation plate, non-bioabsorbable.

Other devices from Wishbone Medical Inc.

See all devices from Wishbone Medical Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (7, all answered No)